HTA-methodology for innovative healthcare technologies

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1 Inn-HTA: HTA-methdlgy fr innvative healthcare technlgies Dr. Bernhard Bührlen 11 th Meeting f the Health Systems Wrking Party Nvember 2008, Luxemburg

2 Decisins t be made in the innvatin prcess (1) time Start animal tests? CT Phase I? CT Phase II? CT Phase III? Market intrductin? Invest in staff and facilities? Start research? Search partners? Public funding necessary? // Patient HCP Authrities Develper/Prducer n f persns treated

3 Market withdrawal? Decisins t be made in the innvatin prcess (2) Buy prduct? time Supprt R&D? Market intrductin? Marketing authrisatin? Price? Reimbursement? Encurage use? Use/prescribe prduct? // Patient HCP Authrities Develper/Prducer n f persns treated

4 Prductin and use f early evidence Prducers f evidence Health Users f evidence Private R&D Hrizn Scanning HTA Regulatry Public/media Public R&D Evidence (Indicatrs) Technl. transfer Inn-? bdy HTA: EBM Bdy Public R&D Private R&D/ prducer HCP Patient Insurance TA Parliaments Ecn./labur Research Envirnment

5 WP3 Inputs/utputs WP1 Health innvatin indicatrs WP2 Early indicatrs used in 'classical' HTA WP4 Case studies WP3 Indicatrs Filtering/ aggregatin List f 221 indicatrs WP5 Online Survey List f 62 indicatrs Final list f?? indicatrs WP6 Recmmendatins Wrk in prgress!

6 Results: Dmains f indicatrs Clinical effectiveness Patient-related utcmes Brader health impacts Safety Ecnmic evaluatin Csts Health ecnmic evaluatin Ecnmic evaluatin prducer perspective Ecnmic evaluatin - Sciety perspective Scietal aspects Ethical aspects Legal aspects Health prblem and current use f technlgy Organisatinal aspects Knwledge/educatin Effrts fr treatment Descriptin and technical characteristics f technlgy Innvativeness Status f develpment Research activities EUnetHTA cre set Inn-HTA additins

7 Indicatrs (examples): Ecnmic evaluatin Csts csts f technlgy (including all relevant indirect cst aspects) Health ecnmic evaluatin incremental cst-effectiveness rati effects n cst-f-illness t sciety affrdability f technlgy cnsumers' willingness t pay reimbursement that health-care prfessinals receive fr technlgy Ecnmic evaluatin prducer perspective prfits (return n investment) f prducer with new technlgy ptential f the market t reward the csts f R&D seed r venture capital available fr R&D Ecnmic evaluatin - Sciety perspective jbs created thrugh R&D, prductin and applicatin f the technlgy

8 Next steps Finalisatin f list Recmmendatins fr utilizatin f results in interactin with "the" HTA cmmunity: Public wrkshp in Cpenhagen 04 December

9 Crdinatin f prductin and use f early evidence Prducers f evidence Health Users f evidence Private R&D Hrizn Scanning HTA Regulatry Public/media Public R&D Evidence (Indicatrs) Technl. transfer bdy "Innvatin management bdies"? EBM Bdy Public R&D Private R&D/ prducer HCP Patient Insurance TA Parliaments Ecn./labur Research Envirnment

10 Framewrk cnditins fr utilisatin Facilitating factrs Evidence (Indicatrs) Prducers f evidence Brkers f evidence Users f evidence? Evidence-based plicy-making Hindrances EB practice

11 Inn-HTA final wrkshp: Prgramme Wrkshp pening - Finn Børlum Kristensen, Natinal Bard f Health, Prject leader EunetHTA, Adjunct Prfessr, University f Suthern Denmark Cnstructive assessment f emerging technlgies: bridging the gap between innvatin and regulatin - Arie Rip, Prfessr f Philsphy f Science and Technlgy, Schl f Management and Gvernance f the University f Twente, The Netherlands Results f Inn-HTA - Bernhard Bührlen, Crdinatr Inn-HTA prject, Fraunhfer Institute fr Systems and Innvatin Research Added value f Inn-HTA in relatin t classic HTA - Kristian Lampe, Senir Medical Officer, FinOHTA, prject leader f EunetHTA WP4 n develping a cre mdel fr HTA Industry perspective - Richard Bergström, Chairman f the Bard f the Swedish industry assciatin (LIF), Vice-chair f EFPIA's HTA Wrking Grup Added value f Inn-HTA fr cnsumers/patients - Cees Smit, The Dutch Genetic Alliance (VSOP), Hnrary member f Eppsi, The Eurpean Platfrm fr Patients' Organisatins, Science and Industry Added value f Inn-HTA t supprt natinal and Eurpean R&D plicy - Fabian Waechter, Austrian fr Health and Fd Safety (AGES) Discussin statins Never t early t evaluate? Panel discussin with Iñaki Gutiérrez Ibarluzea, Basque Office fr HTA, chairman f EurScan, and the speakers

12 Discuss with us the results f Inn-HTA at ur public wrkshp Adding value t cmprehensive early assessment f health care innvatins frm a public and private perspective 4 th f December 2008, Htel Admiral, Cpenhagen please visit

13 This paper was prduced fr a meeting rganized by Health & Cnsumer Prtectin DG and represents the views f its authr n the subject. These views have nt been adpted r in any way apprved by the Cmmissin and shuld nt be relied upn as a statement f the Cmmissin's r Health & Cnsumer Prtectin DG's views. The Eurpean Cmmissin des nt guarantee the accuracy f the data included in this paper, nr des it accept respnsibility fr any use made theref.

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